P rospecto : information for the patient

Tramadol/Paracetamol Krka 37.5 mg/325 mg coated tablets EFG

tramadol hydrochloride/paracetamol

Read this prospect carefully before starting to take this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects , consult your doctor or pharmacist, even if the adverse effects are not listed in this prospect. See section 4.

1. What is Tramadol/Paracetamol Krka and for what it is used

2. What you need to know before starting to use Tramadol/Paracetamol Krka

3. How to take Tramadol/Paracetamol Krka

4. Possible adverse effects

1. Storage of Tramadol/Paracetamol Krka
2. Contents of the package and additional information

Tramadol/Paracetamol Krka is a combination of two analgesics, tramadol and paracetamol, which act together to relieve your pain.

Tramadol/Paracetamol Krka is indicated for the symptomatic treatment of moderate to severe pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

Tramadol/Paracetamol Krka should be taken by adults and adolescents over 12 years old.

Do not take Tramadol/Paracetamol Krka

• If you are allergic to tramadol hydrochloride, paracetamol, or any of the other components of this medication (listed in section 6).
• If you are experiencing acute intoxication with alcohol, sleeping pills, analgesics, or other psychotropic medications (medications that affect mood and emotions).
• If you are taking monoamine oxidase inhibitors (MAOIs) (certain medications used to treat depression or Parkinson's disease) or have taken them in the last 14 days before starting treatment with this medication.
• If you have a severe liver disease.
• If you have uncontrolled epilepsy.

Warnings and Precautions

Consult your doctor before starting to take Tramadol/Paracetamol Krka if you:

• are taking other medications that contain paracetamol or tramadol;
• have liver problems or liver disease or if you notice that your eyes or skin turn yellow. This may indicate jaundice or problems with your bile ducts;
• have kidney problems;
• have severe respiratory difficulties, for example, asthma or severe lung problems;
• are epileptic or have had seizures or convulsions;
• are experiencing depression and taking antidepressants, as some may interact with tramadol (see "Taking Tramadol/Paracetamol Krka with other medications");
• have recently experienced head trauma, shock, or severe headaches associated with vomiting;
• are dependent on any other medication used to relieve pain, for example, morphine;
• are taking other pain medications that contain buprenorphine, nalbuphine, or pentazocine;
• are scheduled for anesthesia. Inform your doctor or dentist that you are taking tramadol/paracetamol.

Tolerance, dependence, and addiction

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (you become tolerant of it, known as tolerance). Repeated use of tramadol/paracetamol can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these side effects may increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel like you no longer control the amount of medication you need to take or how often you need to take it.

The risk of becoming dependent or addicted to tramadol/paracetamol varies from person to person. You may be at a higher risk of becoming dependent or addicted to tramadol/paracetamol if:

• You or someone in your family has abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction");
• You are a smoker;
• You have had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental health conditions;

If you notice any of the following signs while taking tramadol/paracetamol, it could be a sign that you have become dependent or addicted:

• You need to take the medication for longer than recommended by your doctor;
• You need to take more of the recommended dose;
• You use the medication for reasons other than those prescribed, for example, "to stay calm" or "to sleep";
• You have repeatedly tried and failed to stop or control the use of the medication;
• You feel unwell when you stop taking the medication, and you feel better when you take it again ("withdrawal symptoms");

If you notice any of these signs, talk to your doctor to determine the best course of treatment for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, If you interrupt treatment with tramadol/paracetamol).

Respiratory problems related to sleep

Tramadol/Paracetamol Krka contains an active ingredient that belongs to the opioid group. Opioids can cause respiratory problems related to sleep; for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and hypoxemia related to sleep (low oxygen levels in the blood).

The risk of experiencing central sleep apnea depends on the dose of opioids. Your doctor may consider reducing the total dose of opioids if you experience central sleep apnea.

There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult your doctor immediately if you experience any of the symptoms associated with this severe syndrome (see section 4 "Possible side effects").

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, it may be possible to achieve insufficient pain relief, while others may be more likely to experience severe side effects. If you notice any of the following side effects, stop taking this medication and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

If you experience or have experienced any of these problems while taking tramadol/paracetamol, please inform your doctor. They will decide whether you should continue taking this medication.

Children and adolescents

Use in children with respiratory problems

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Consult your doctor if you experience any of the following symptoms while taking this medication:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, contact your doctor, who will decide if you need to take a hormone supplement.

Other medications and Tramadol/Paracetamol Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Important:This medication contains paracetamol and tramadol. Inform your doctor if you are taking any other medication that contains paracetamol or tramadol, so that you do not exceed the maximum daily dose.

Do not takethis medicationwith monoamine oxidase inhibitors (MAOIs) (see "Do not take Tramadol/Paracetamol Krka").

Do not use Tramadol/Paracetamol Krka if you are being treated with:

• carbamazepine (a medication normally used to treat epilepsy or certain types of pain, such as trigeminal neuralgia),
• buprenorphine, nalbuphine, or pentazocine (opioid analgesic). Pain relief may be reduced.

Inform your doctor or pharmacist if you are taking:

• flucloxacillin (antibiotic), due to a severe risk of blood and fluid disorder (metabolic acidosis with high anion gap, which occurs when the plasma blood becomes more acidic) that must be treated urgently and may occur particularly in cases of severe renal or hepatic failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and if you use the maximum daily dose of paracetamol, especially if you use the maximum daily dose of paracetamol for a longer period. Metabolic acidosis with high anion gap is a serious disease that must be treated urgently.

The risk of side effects increases if you also use:

• triptans (for the treatment of migraines) or selective serotonin reuptake inhibitors (SSRIs) (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, involuntary muscle contractions, or diarrhea, you should call your doctor.
• other pain medications such as morphine and codeine (also cough medications), baclofen (muscle relaxant), some medications to lower blood pressure, or medications for allergy treatment. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• The concomitant use of Tramadol/Paracetamol Krka and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes this medication with sedatives, you should limit the dose and duration of concomitant treatment. Inform your doctor of all sedatives you are taking and strictly follow your doctor's recommended dose. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms.
• medications that can cause seizures (attacks), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take this medication at the same time. Your doctor will tell you if tramadol/paracetamol is suitable for you.
• certain antidepressants. Tramadol/paracetamol may interact with these medications and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• warfarin or phenprocoumon (a medication used to prevent blood clots). The effectiveness of these medications may be altered, with a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.
• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

The effectiveness of Tramadol/Paracetamol Krka may be altered if you also use:

• metoclopramide, domperidone, or ondansetron (medications for nausea and vomiting),
• colestiramine (a medication that reduces cholesterol in the blood).

Your doctor will indicate which medications are safe to use with tramadol/paracetamol.

Taking Tramadol/Paracetamol Krka with food and alcohol

Tramadol/paracetamol may make you feel drowsy. Alcohol may make you feel more drowsy, so it is recommended not to drink alcohol while taking this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Due to the fact that this medication contains tramadol, it is not recommended to take it during pregnancy or breastfeeding. If you become pregnant while taking tramadol/paracetamol, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not take this medication more than once while breastfeeding, or alternatively, if you are taking this medication more than once, you should stop breastfeeding.

Fertility

Based on human experience, it is considered that tramadol does not affect female or male fertility. There are no available data on the influence of tramadol and paracetamol on fertility.

Ask your doctor or pharmacist for advice before taking any medication.

Driving and using machines

Tramadol/paracetamol may make you feel drowsy, which can affect your ability to drive or use tools and machines safely.

Tramadol/Paracetamol Krka contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will explain to you what you can expect from the use of tramadol/paracetamol, when and for how long you should take it, when you should contact your doctor and when you should discontinue it (see also section 2).

You should take tramadol/paracetamol for the shortest time possible.

This medication is not recommended for use in children under 12 years old.

The dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest dose possible that produces pain relief should be used.

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents over 12 years old is 2 tablets.

If necessary, you can increase the dose as recommended by your doctor. The shortest interval between doses should be at least 6 hours.

Do not take more than 8 tablets per day.

Do not take tramadol/paracetamol more frequently than your doctor has indicated.

Patients over 75 years old

In patients over 75 years old, tramadol excretion may be delayed. If this is your case, your doctor may recommend prolonging the dosing intervals.

Patients with severe liver or kidney failure/dialysis

Patients with severe renal and/or hepatic failure should not take this medication.

If your liver or kidney failure is mild or moderate, your doctor may recommend prolonging the dosing interval.

Administration route

The tablets should be administered orally.

They should be swallowed whole with sufficient liquid. The tablets should not be broken or chewed.

If you believe the effect of this medication is too strong (e.g., if you feel very drowsy or have difficulty breathing) or too weak (e.g., if you have inadequate pain relief), contact your doctor.

If you take more Tramadol/Paracetamol Krka than you should

In these cases, contact your doctor or pharmacist immediately, even if you feel well.There is a risk of severe liver damage that may only become apparent later.

For accidental ingestion or overdose, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Tramadol/Paracetamol Krka

If you forget to take a dose of this medication, it is likely that the pain will recur. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you discontinue treatment with Tramadol/Paracetamol Krka

You should not suddenly stop taking this medication unless your doctor advises you to do so. If you want to stop taking your medication, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to discontinue it, which can be done by gradually reducing the dose to reduce the risk of unnecessary side effects (withdrawal symptoms).

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Very common (may affect more than 1 in 10 people):

• nausea,

• dizziness, drowsiness.

Common (may affect up to 1 in 10 people):

• vomiting, digestive problems (constipation, flatulence, diarrhea), abdominal pain, dry mouth,
• itching, increased sweating (hyperhidrosis),
• headache, tremors,
• confusion, sleep disorders, mood changes (anxiety, nervousness, feeling "euphoric").

Uncommon (may affect up to 1 in 100 people):

• increased heart rate or increased blood pressure, cardiac rhythm and frequency disorders,

• tingling, numbness, or pins and needles sensation in the extremities, ear noises, involuntary muscle spasms,
• depression, nightmares, hallucinations (hearing, seeing, or perceiving something that does not exist in reality), memory loss,
• difficulty breathing,
• difficulty swallowing, blood in the stool,
• skin reactions (e.g. rashes, urticarial hives),
• increased liver enzyme values,
• albumin in the urine, difficulty or pain urinating,
• chills, hot flashes, chest pain.

Rare (may affect up to 1 in 1,000 people):

• seizures, difficulties with coordinated movements, transient loss of consciousness (syncope),

• dependence on the medication,
• delirium,
• blurred vision, pupil constriction (miosis),
• speech disorders,
• excessive pupil dilation (midriasis).

Very rare (may affect up to 1 in 10,000 people):

• drug addiction.

Not known (frequency unknown):

• low blood sugar (hypoglycemia).

The following adverse effects recognized have been reported by people who have taken medications containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking this medicine, you should tell your doctor:

• lightheadedness when standing up after lying down or sitting, slowing of heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception, worsening of asthma.
• the use of paracetamol alone or when taken with the antibiotic flucloxacillin may induce an anomaly in the blood and fluids (metabolic acidosis with high anion gap) when there is an increase in plasma acidity.
• The use of tramadol/paracetamol with anticoagulants (e.g. fenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.
• in rare cases, skin rashes, indicative of allergic reactions that may manifest through sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness. If this happens to you,interrupt the treatment and consult your doctor immediately. Do not take this medicine again.

In rare cases, using a medication like tramadol can make you dependent on it, making it difficult to stop taking it.

In rare instances, people who have been taking hydrochloride tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous, or tremulous. They may be hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disorders. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ear noises (tinnitus). If you experience any of these symptoms after stopping treatment, please consult your doctor.

Unknown frequency: hiccups.

Serotonin syndrome, which may manifest through changes in mental state (e.g. agitation, hallucinations, coma), and other effects, such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "What you need to know before taking Tramadol/Paracetamol Krka").

In exceptional cases, blood tests may reveal certain abnormalities, such as low platelet count, which may result in nasal or gum bleeding.

Very rare cases of cutaneous adverse reactions have been described for medications containing paracetamol.

Rare cases of respiratory depression with tramadol have been reported.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store this medication in a safe and protected place, where other people cannot access it. It may cause serious harm and be fatal to individuals who have not been prescribed it.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Tramadol/Paracetamol Krka

• The active ingredients are tramadol hydrochloride and paracetamol. Each film-coated tablet contains 37.5 mg of tramadol hydrochloride equivalent to 32.94 mg of tramadol and 325 mg of paracetamol.
• The other components are:

• core of the tablet:almidon of maize pregelatinized, carboxymethylstarch sodium of potato (type A), microcrystalline cellulose (E460) and magnesium stearate (E470b).
• coating:hypromellose, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172) and polysorbate 80.See section 2 “Tramadol/Paracetamol Krka contains sodium”.

Appearance of Tramadol/Paracetamol Krka and contents of the package

Film-coated tablets, yellow-brown, oval, slightly biconvex.

They are available in packs of 2 film-coated tablets (blister packs with 2 tablets) or 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 film-coated tablets (blister packs with 10 tablets).

Only some pack sizes may be marketed.

Holder of the marketing authorization

KRKA, d.d.,

Novo mesto, Šmarješka cesta 6,

8501 Novo mesto,

Slovenia

Responsible for manufacturing

KRKA, d.d.,

Novo mesto, Šmarješka cesta 6,

8501 Novo mesto,

Slovenia

or

TAD Pharma GmbH,

Heinz-Lohmann-Straße 5,

27472 Cuxhaven,

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L.,

C/ Anabel Segura 10, Pta. Baja, Oficina 1,

28108 Alcobendas, Madrid,

Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Date of the last review of this leaflet:October 2024

The detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)